1.An application for an authorisation as provided for in Article 4 shall be sent to the Commission. The Commission shall without delay inform the Member States and forward the application to the European Food Safety Authority (hereinafter referred to as the Authority).
2.The Authority shall:
(a)acknowledge receipt of the application, including the particulars and documents referred to in paragraph 3, in writing, to the applicant within 15 days of its receipt, stating the date of receipt;
(b)make any information supplied by the applicant available to the Member States and the Commission;
(c)make the summary of the dossier mentioned in paragraph 3(h) available to the public, subject to the confidentiality requirements laid down in Article 18(2).
3.At the time of application, the applicant shall send the following particulars and documents directly to the Authority:
(a)his name and address;
(b)the identification of the feed additive, a proposal for its classification by category and functional group under Article 6, and its specifications, including, where applicable, purity criteria;
(c)a description of the method of production, manufacturing and intended uses of the feed additive, of the method of analysis of the additive in feed according to its intended use and, where appropriate, of the method of analysis for the determination of the level of residues of the feed additive, or its metabolites, in food;
(d)a copy of the studies which have been carried out and any other material which is available to demonstrate that the feed additive satisfies the criteria laid down in Article 5(2) and (3);
(e)proposed conditions for placing the feed additive on the market, including labelling requirements and, where appropriate, specific conditions for use and handling (including known incompatibilities), use levels in complementary feedingstuffs and animal species and categories for which the feed additive is intended;
(f)a written statement that three samples of the feed additive have been sent by the applicant directly to the Community reference laboratory referred to in Article 21, in accordance with the requirements set out in Annex II;
(g)for additives which, according to the proposal under point (b), do not belong to either category (a) or category (b) referred to in Article 6(1), and for additives falling within the scope of Community legislation relating to the marketing of products consisting of, containing or produced from GMOs, a proposal for post-market monitoring;
(h)a summary containing the information provided under points (a) to (g);
(i)for additives falling within the scope of Community legislation relating to the marketing of products consisting of, containing or produced from GMOs, details of any authorisation granted in accordance with the applicable legislation.
4.The Commission, having first consulted the Authority, shall establish, in accordance with the procedure laid down in Article 22(2), implementing rules for the application of this Article, including rules concerning the preparation and the presentation of the application.
Until such implementing rules are adopted, the application shall be made in accordance with the Annex to Directive 87/153/EEC.
5.After the Authority has been consulted, specific guidelines for the authorisation of additives shall be established, where necessary for each category of additive referred to in Article 6(1) in accordance with the procedure laid down in Article 22(2). These guidelines shall take account of the possibility of extrapolating the results of the studies carried out on major species to minor species.
[F1After the Authority has been consulted, further rules for the implementation of this Article may be established.
Rules to allow for simplified provisions for the authorisation of additives which have been authorised for use in food shall be laid down by the Commission. Those measures, designed to amend non-essential elements of this Regulation, inter alia , by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 22(3).
Other implementing rules may be adopted in accordance with the regulatory procedure referred to in Article 22(2). Those rules should, where appropriate, differentiate between requirements for feed additives in respect of food-producing animals and requirements in respect of other animals, in particular pets.]
6.The Authority shall publish detailed guidance to assist the applicant in the preparation and the presentation of its application.
Textual Amendments
F1 Substituted by Regulation (EC) No 596/2009 of the European Parliament and of the Council of 18 June 2009 adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny Adaptation to the regulatory procedure with scrutiny — Part Four.